Is there a "list" of what are termed Special Processes that have to be validated?

[ganglai]

Thanks.
A little curious that

Yes, I think so. I have done this for the sterilization process requirement within ISO 13485. I did not take an exclusion but covered it in the manual by stating that if there was a need for it in the future a procedure would be developed. Also, we do not incorporate customer supplied product, but did not exclude it.

Usually, if a compant does not have R&D, the requirement of Design control will be excluded fromt the scope of the certification. But not for the case of special process and customer supplied products. So how does it work?

This seems like a special process. I think the key to this is in how you are able verify the results of the process. I think that if you can't verify it without destroying the product, it is a special process.

What if the charactor of the product is control using another indicator. For example, fire resistance of a product. We have to light up the product to do the test, but the process is controlled by mornitoring how much fire resistant compound has been applied. Is it still a special process.

 

[Al Rosen]

Thanks.
A little curious that

Usually, if a compant does not have R&D, the requirement of Design control will be excluded fromt the scope of the certification. But not for the case of special process and customer supplied products. So how does it work?


What if the charactor of the product is control using another indicator. For example, fire resistance of a product. We have to light up the product to do the test, but the process is controlled by mornitoring how much fire resistant compound has been applied. Is it still a special process.

That's the point of it. It's a special process that has to be validated and controlled through characteristics of the process.

 

[Paul Simpson]

Definitions

I'll add something else to think about: In the sense that "validate" is used here, all processes should be validated, because "validation" is just a synonym for "process control."

There is a difference between the general process planning (covered in 7.1) and process validation (7.5.2). The process validation would be a subset of process planning and is specifically to do with those processes where you cannot verify the product / service afterwards. There are lots of good examples in the thread of what are "special processes" (terminology from earlier versions of ISO)

The object should be to control processes to the extent necessary to avoid after-the-fact inspection. Processes are validated, not products. Products are inspected. If it's possible to avoid inspection in "special" processes, it's already been proven that it's possible for all processes.

I agree with the principle and process planning (7.1) should be applied to minimize the non value adding inspection / measurement but process design, development for those processes that can be verified after the fact mustn't be confused with the requirement to demonstrate validation of processes that cannot subsequently be verified.

 

[Jim Wynne]

There is a difference between the general process planning (covered in 7.1) and process validation (7.5.2). The process validation would be a subset of process planning and is specifically to do with those processes where you cannot verify the product / service afterwards. There are lots of good examples in the thread of what are "special processes" (terminology from earlier versions of ISO)

I understand. My point was that if one process can be "validated," there's no reason why all processes can't be validated. I'm pretty sure that process control that extends to validation for all processes wouldn't violate the standard.

I agree with the principle and process planning (7.1) should be applied to minimize the non value adding inspection / measurement but process design, development for those processes that can be verified after the fact mustn't be confused with the requirement to demonstrate validation of processes that cannot subsequently be verified.

True, if it's assumed that validation isn't a good idea for all processes, but I can't think of a good reason that it wouldn't be.

 

[Statistical Steven]

There is a difference between the general process planning (covered in 7.1) and process validation (7.5.2). The process validation would be a subset of process planning and is specifically to do with those processes where you cannot verify the product / service afterwards. There are lots of good examples in the thread of what are "special processes" (terminology from earlier versions of ISO)

Even processes that you can verify afterwards need to be validated in many industries. Process validation is a systematic methodology for assessing the process performance. From these studies, one can determine the inherent variability of the process, and the ultimate need for inspection. Just because you can measure something afterwards, does not mean it does not need to be validated.

 

[Caster]

TS add on

Before we get stuck in mud over special processes, let's remember, all processes must be validated and controlled, and all personnel must be competent to perform the work assigned to them.

The purpose for deeming some as "special," is simply because they cannot be easily measured to determine conformity. In those cases, additional and alternate steps need to be found, to ensure product does in fact meet the requirements. ...

hjilling

Very nicely said. I will use this from now on - if you don't mind. Best description I have ever seen.

TS16949 makes this whole debate moot with this ISO add on.

7.5.2.1 Validation of processes for production and service provision — Supplemental
The requirements of 7.5.2 shall apply to all processes for production and service provision.

Too bad they didn't use your very clear wording...I might have known why they did this to us.

Now isn't that special !​

 

[Paul Simpson]

Agree with the principle

Even processes that you can verify afterwards need to be validated in many industries. Process validation is a systematic methodology for assessing the process performance. From these studies, one can determine the inherent variability of the process, and the ultimate need for inspection. Just because you can measure something afterwards, does not mean it does not need to be validated.

It all comes down to risk. The reason for ISO requiring process validation for "special processes" is that you cannot demonstrate they conform any other way (within reason). I agree there are many reasons why you might want to validate a process even though there is no requirement. Process repeatability and the ease of identifying failures are factors you might consider.

In many industries there is little process planning and even less process verification / validation. Not an ideal situation but that is the fact.

 

[Rockanna]

Special Processes

I will give my two cents - our special processes include welding, heat treat, chrome plating and phosphating - it's worth 2 bits.

 

[ralphsulser]

I will give my two cents - our special processes include welding, heat treat, chrome plating and phosphating - it's worth 2 bits.

Yes, these are good examples and external auditors will consider these a special processes too.

 

[heidi cai]

There is a list in the guidance from GHTF (GHTF/SG3/N99-10:2004 edition2).


3.2 Examples
The following table is a list of examples of processes which: (1) should be validated, (2) may be
satisfactorily covered by verification, and (3) processes which may be verifiable, but for business
purposes, validation can be chosen.
(1) Processes which should be validated
· Sterilization processes
· Clean room ambient conditions
· Aseptic filling processes
· Sterile packaging sealing processes
· Lyophilization process
· Heat treating processes
· Plating processes
· Plastic injection molding processes
(2) Processes which may be satisfactorily covered by verification
· Manual cutting processes
· Testing for color, turbidity, total pH for solutions
· Visual inspection of printed circuit boards
· Manufacturing and testing of wiring harnesses
(3) Processes for which the above model may be useful in determining the need for
validation
· Certain cleaning processes
· Certain human assembly processes
· Numerical control cutting processes
· Certain filling processes